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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K132065
Device Name INJECTION NEEDLE
Applicant
ENDOCHOICE, INC.
11810 WILLS ROAD
ALPHARETTA,  GA  30009
Applicant Contact THERON GOBER
Correspondent
ENDOCHOICE, INC.
11810 WILLS ROAD
ALPHARETTA,  GA  30009
Correspondent Contact THERON GOBER
Regulation Number876.1500
Classification Product Code
FBK  
Date Received07/03/2013
Decision Date 01/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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